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Orthopedic

17,044 FDA 510(k) clearances · Medical specialty

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RecordFirmDate
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES (K041081)Hand Innovations, Inc.2004-07-01
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) (K041466)Biomet Manufacturing Corp2004-07-01
SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM (K040096)Spinal Concepts, Inc.2004-07-01
LPS (K033959)Depuy, Inc.2004-07-01
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K041556)Medtronic Sofamor Danek2004-07-01
LACTOSCREW SCREW ANCHOR (K033355)Biomet Orthopedics, Inc.2004-06-30
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K041030)Medtronic Sofamor Danek2004-06-30
OPUS MAGNUM ANCHOR WITH INSERTER (K041440)Opus Medical, Inc.2004-06-25
EBI DISTAL RADIUS PLATING SYSTEM (K040908)Ebi, L.P.2004-06-25
CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL (K041425)Wrightmedicaltechnologyinc2004-06-25
WAFER SYSTEM (K033303)Spine Wave, Inc.2004-06-24
TSY SHOULDER PLATE IMPLANT (K040850)Orthopedic Sciences, Inc.2004-06-24
BIO-EUROLIG INTERFERENCE SCREW (K031939)Fournitures Hospitalieres Industrie2004-06-24
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K041452)Medtronic Sofamor Danek2004-06-24
LCP RADIAL HEAD PLATING SYSTEM (K040777)Synthes (Usa)2004-06-18
ALADYN RIGID SPINE PLATE (K040747)Scient'X2004-06-17
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE (K040755)Exactech, Inc.2004-06-17
INTEGRA BONE FIXATION SYSTEM (K040860)Integra LifeSciences Corporation2004-06-17
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS (K040749)Howmedica Osteonics Corp.2004-06-17
ASSURE ANTERIOR CERVICAL PLATE SYSTEM (K040721)Globus Medical, Inc.2004-06-17
AEQUALIS SHOULDER SYSTEM (K041339)Tornier2004-06-17
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) (K040612)Disc-O-Tech Medical Technologies, Ltd.2004-06-17
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS (K040701)Synthes (Usa)2004-06-15
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM (K041307)Stryker Endoscopy2004-06-14
CONTOUR HA COATED RECONSTRUCTION RING (K040680)Smith & Nephew, Inc.2004-06-14
STRYKER WEDGE SUTURE ANCHOR SYSTEM (K041310)Stryker Endoscopy2004-06-14
STRYKER BIOZIP SUTURE ANCHOR SYSTEM (K041305)Stryker Endoscopy2004-06-14
MODIFICATION TO TSRH SPINAL SYSTEM (K041282)Medtronic Sofamor Danek, Inc.2004-06-10
JAX-TCP (K033552)Smith & Nephew, Inc.2004-06-10
MODIFICATION TO SMARTPIN (K041288)Linvatec Biomaterials, Inc.2004-06-10
FEMORAL HOOK (K041261)Arthrotek, Inc.2004-06-07
MODULAR RADIAL HEAD REPLACEMENT DEVICE (K040611)Biomet, Inc.2004-06-04
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS (K040613)Exactech, Inc.2004-06-04
VERSA-DIAL HUMERAL HEAD (K040610)Biomet Manufacturing, Inc.2004-06-04
PROCYON SPINAL SYSTEM (K033512)Nas Medical Technologies, Inc.2004-06-03
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN (K033489)Biomet, Inc.2004-06-02
SWIFT ANTERIOR CERVICAL PLATE SYSTEM (K040655)Depuy Spine, Inc.2004-06-02
SUMMIT OCT SPINAL SYSTEM (K041203)Depuy Spine, Inc.2004-06-02
NUCLEOTOME PROBE SET, MODEL 21200 (K040919)Clarus Medical, LLC2004-06-01
PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 (K041117)Depuy Mitek2004-05-28
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K041118)Medtronic Sofamor Danek2004-05-28
LITTLE GRAFTER SCREW (K040265)Biocomposites, Ltd.2004-05-28
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS (K040964)Howmedica Osteonics Corp.2004-05-28
PROFEMUR TAPERED HIP STEM (K041114)Wrightmedicaltechnologyinc2004-05-28
GII QUICKANCHOR PLUS (K041115)Depuy Mitek, A Johnson & Johnson Company2004-05-28
SUPER QUICKANCHOR PLUS (K041116)Depuy Mitek2004-05-28
MODIFICATION TO BONE GRAFT WASHER (K041217)Medtronic Sofamor Danek, Inc.2004-05-28
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 (K040544)Depuy, Inc.2004-05-28
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING (K033971)Howmedica Osteonics Corp.2004-05-28
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS (K032522)Exactech, Inc.2004-05-28
AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT (K041160)Howmedica Osteonics Corp.2004-05-27
SPINAL CONCEPTS INC. CODA (K033663)Spinal Concepts, Inc.2004-05-27
ARTHROTEK LACTONAIL (K040500)Arthrotek, Inc.2004-05-25
TRIGEN ADOLESCENT TAN (K040929)Smith & Nephew, Inc.2004-05-25
TRIDENT T ACETABULAR SHELLS (K040412)Stryker Orthopaedics2004-05-25
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW (K040656)Smith & Nephew, Inc.2004-05-25
REFOBACIN -PALACOS G (K031673)Heraeus Kulzer GmbH & Co. KG2004-05-25
SIMPLEX X (K032945)Stryker Corp.2004-05-25
MAXIM ACCEL (VANGUARD) PS+ BEARINGS (K041046)Biomet, Inc.2004-05-21
MICROMAX SUTURE ANCHOR (K040475)Biomet, Inc.2004-05-21
PROTEX STABILIZATION SYSTEM (K040442)Globus Medical, Inc.2004-05-20
COONRAD/MORREY ELBOW CEMENT RESTRICTOR (K040389)Zimmer, Inc.2004-05-17
AEQUALIS REVERSED SHOULDER PROSTHESIS (K030941)Tornier2004-05-14
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE) (K040017)Aesculap, Inc.2004-05-14
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K040962)Medtronic Sofamor Danek2004-05-14
BIOKNOTLESS RC ANCHOR (K041064)Depuy Mitek2004-05-13
KLS MARTIN HAND PLATING SYSTEM (K040598)KLS-Martin L.P.2004-05-13
SKY BONE EXPANDER SYSTEM (SKY SYSTEM) (K040939)Disc-O-Tech Medical Technologies, Ltd.2004-05-12
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 (K040381)Arthrex, Inc.2004-05-12
TRIFLANGE II ACETABULAR CUP SYSTEM (K040383)DePuy Orthopaedics, Inc.2004-05-12
ENDOTINE TRANSBLEPH DEVICE (K040740)Coapt Systems, Inc.2004-05-10
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES (K041135)Depuy Mitek, A Johnson & Johnson Company2004-05-10
CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT (K033596)Exactech, Inc.2004-05-10
APAPORE BONE GRAFT SUBSTITUTE (K033722)Apatech , Ltd.2004-05-07
OSTEO ACL SCREW MODEL;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T, (K032894)Linvatec Biomaterials, Inc.2004-05-07
PANALOK RC LOOP ANCHOR (K041065)Depuy Mitek2004-05-07
GENEX BONE GRAFT SUBSTITUTE (K040600)Biocomposites, Ltd.2004-05-07
SYNTHES (USA) 2.4 MM LCP WRIST PLATE (K040588)Synthes (Usa)2004-05-07
BIOFILL BONE VOID FILLER (K040454)Scient'X2004-05-07
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS (K033273)DePuy Orthopaedics, Inc.2004-05-06
OTI ALUMINA CERAMIC FEMORAL HEAD SYSTEM (K040225)Osteoimplant Technology, Inc.2004-05-06
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM (K040397)Encore Medical L.P.2004-05-06
MODIFICATION TO VERTE-STACK SPINAL SYSTEM (K040536)Medtronic Sofamor Danek2004-05-05
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE (K040267)Howmedica Osteonics Corp.2004-05-05
DEPUY PRESERVATION UNICONDYLAR TIBIA (K040268)DePuy Orthopaedics, Inc.2004-05-05
CERAFORM BONE VOID FILLER (K040669)Teknimed, S.A.2004-05-03
EOVIA CALCIUM PHOSPHATE CERAMIC (K040514)Ortho Tec, LLC2004-05-03
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES (K031687)Vanguard Medical Concepts, Inc.2004-04-30
PANALOK LOOP ANCHOR (K040827)Depuy Mitek, A Johnson & Johnson Company2004-04-30
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM (K040833)Ebi, L.P.2004-04-29
VERSABOND AB BONE CEMENT (K022688)Smith & Nephew, Inc.2004-04-29
MS-30 FEMORAL STEM STANDARD AND LATERAL (K040803)Zimmer, Inc.2004-04-29
CALCIGEN -NAP BONE VOID FILLER (K033611)Biomet, Inc.2004-04-27
VANGUARD PATELLA COMPONENTS (K040770)Biomet Manufacturing, Inc.2004-04-22
MODIFICATION TO CD HORIZON SPINAL SYSTEM (K034056)Medtronic Sofamor Danek2004-04-21
CANNULATED NUGEN FX SCREW FULLY THREADED, CANNULATED NUGEN FX SCREW PARTIALLY THREADED (K032447)Linvatec Biomaterials, Ltd.2004-04-16
KATALYST RADIAL HEAD IMPLANT (K032806)Kinetikos Medical, Inc.2004-04-16
IM TOTAL FEMUR (K033871)Biomet, Inc.2004-04-16
EBI ESL SPINE SPACER SYSTEM (K040482)Ebi, L.P.2004-04-16
REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM (K040261)Stryker Spine2004-04-16
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